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临床试验/NCT01047020
NCT01047020已完成不适用

Motor Proficiency And Physical Activity in Adult Survivors of Childhood ALL

St. Jude Children's Research Hospital1 个研究点 分布在 1 个国家目标入组 807 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
807
试验地点
1
主要终点
Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.

研究概览

简要总结

The primary goal of this study is to provide comprehensive and objective information on impairments of musculoskeletal health, sensory function, and fitness among a large group of childhood ALL survivors, and to define high risk groups by assessing treatment factors that contribute to impaired function. This study includes a direct, objective evaluation of musculoskeletal function, sensory capacity, fitness, and physical activity patterns among adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH) between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an institutionally funded clinical study of medical late effects, the study will recruit 364 to participate in our evaluations. The study will also recruit 364 individuals for a comparison group, frequency matching on race/ethnicity, age and gender.

详细描述

The study will focus on the following primary objectives:

  1. Enumerate the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL will have a higher prevalence of musculoskeletal, sensory and fitness impairments than a control group frequency matched on race/ethnicity, age, and gender.
  2. Evaluate the association between personal and treatment factors and musculoskeletal, sensory and fitness impairments. The study hypothesizes that:
  • Female gender, younger age at diagnosis, and cranial radiation will be associated with decreased lean body mass.
  • Female gender, younger age at diagnosis, and type of glucocorticoid (dexamethasone vs. prednisone) treatment will be associated with muscle weakness.
  • Sensory loss will vary as a function of age, with participants diagnosed at 12+ years of age demonstrating vincristine related sensory loss, and those diagnosed at <12 years of age demonstrating dexamethasone and/or intrathecal methotrexate related sensory loss.
  • Fitness impairments will be evident in participants who received 100 mg/m2+ of anthracyclines.

The study will focus on the secondary objectives:

  1. Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group. The study hypothesizes that adult survivors of childhood ALL will demonstrate lower levels of physical activity as measured with an activity monitor (accelerometer), and will report lower levels of overall physical activity, when compared to members of the comparison group.
  2. Describe the association between habitual physical activity and energy expenditure among ALL survivors. The study hypothesizes that activity levels, measured with the accelerometer, will be positively correlated with energy expenditure, measured using the doubly labeled water technique.
  3. Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL with lower proportions of lean muscle mass and/or sensory loss indicating peripheral neuropathy will demonstrate the lowest levels of physical activity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (ALL survivors):
  • Research participant who is a survivor of childhood ALL who was treated at St. Jude Children's Research Hospital between 1980 and 1999
  • Research participant must be at least ten years from diagnosis
  • Research participant must be at least 18 years of age at the time of the scheduled evaluation
  • Exclusion Criteria (ALL survivors):
  • Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
  • Research participant currently pregnant or lactating
  • Research participant age 17 years or less
  • Research participant undergoing active treatment for cancer
  • Inclusion Criteria (Comparison Group)
  • Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient.
  • Research participant must be at least 18 years of age at the time of the scheduled evaluation
  • Exclusion Criteria (Comparison Group)
  • Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
  • Research participant currently pregnant or lactating
  • Research participant age 17 years or less
  • Research participant has a medical history of cancer
  • Research participant is a first degree relative of a survivor participating in MTRPAL

排除标准

  • 未提供

结局指标

主要结局

Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.

时间窗: Day 1-2

次要结局

  • Describe the association between habitual physical activity and energy expenditure among ALL survivors.(Day 1-7)
  • Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.(Day 1-7)
  • Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL.(Day 1-7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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